WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is set to review Moderna’s new flu vaccine made with Nobel prize-winning mRNA technology, reversing course after the agency declined to review it earlier this month.
The FDA said it initially declined the review due to concerns over the testing process, but did not identify any safety concerns about the vaccine.
Moderna is now seeking full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older. A follow-up study is planned as part of the approval process.
The FDA is aiming to make a decision on approval by August 5.
